Boundless Bio Announces Pipeline and Leadership Updates
December 12 2024 - 3:01PM
Boundless Bio (Nasdaq: BOLD), a clinical-stage oncology company
interrogating extrachromosomal DNA (ecDNA) biology to deliver
transformative therapies to patients with previously intractable
oncogene amplified cancers, today announced updates to its
portfolio of ecDNA directed therapy (ecDTx) programs and to its
executive leadership team.
Pipeline UpdatesBoundless announced the
following updates to its portfolio of novel ecDTx programs for a
range of aggressive and difficult-to-treat cancer indications:
- Initial clinical data readout for BBI-355 on track for
the second half of 2025: Enrollment is ongoing in
Boundless’s Phase 1/2 POTENTIATE clinical trial, which is
evaluating BBI-355 both as a single agent and in combination with
targeted therapies for patients with oncogene-amplified solid
tumors. BBI-355 is a novel, oral, and potent CHK1 inhibitor
specifically designed to target replication stress in
oncogene-amplified cancers. The company has reaffirmed its
expectation to report preliminary clinical proof-of-concept safety
and antitumor activity data in the second half of 2025.
- Decision not to advance BBI-825 into Part 2 portion of
STARMAP trial: Boundless has been evaluating BBI-825, an
oral RNR inhibitor, in the Phase 1/2 STARMAP clinical trial for
patients with solid tumors, including those with BRAFV600E or
KRASG12C mutated colorectal cancer that has developed resistance
oncogene amplifications. To date, BBI-825 has been generally
well-tolerated. Following an assessment of preliminary
pharmacokinetic data from the Part 1 portion of the trial showing a
lack of dose-proportional exposure, and the increasing complexity
and associated development costs related to the evolving BRAFV600E
and KRASG12C mutated cancer treatment landscape, Boundless has made
the strategic decision not to continue dose escalation of Part 1 or
to proceed into the Part 2 portion of the STARMAP trial.
- Third ecDTx program advances, with development
candidate nomination expected by mid-2025: Boundless has
progressed its ecDTx 3 program targeting a previously undrugged
kinesin essential for ecDNA segregation and expects to select a
development candidate by mid-2025. The company has reaffirmed that
it expects to submit an Investigational New Drug (IND) application
in the first half of 2026.
Leadership Transitions Boundless also announced
that Klaus Wagner, M.D., Ph.D., Chief Medical Officer (CMO), and
Neil Abdollahian, Chief Business Officer (CBO), will depart the
company at the end of December and in early January, respectively.
James L. Freddo, M.D., current advisor to Boundless with nearly 30
years of clinical leadership experience in biopharmaceutical
companies, will serve as Interim CMO while the company conducts a
search for a permanent hire. Dr. Freddo’s extensive background
includes serving as CMO and later as a member of the board of
directors at Ignyta, Inc., CMO and Senior Vice President,
Development at Anadys Pharmaceuticals, and Vice President, Clinical
Development, Oncology at Pfizer. Boundless does not intend to
appoint a new CBO at this time.
“After a thorough assessment of BBI-825’s emerging clinical data
and anticipated development costs, particularly amid the dynamic
and increasingly competitive landscape of BRAFV600E and
KRASG12C-mutated cancer treatment, we have decided not to advance
the STARMAP trial. We are grateful to our team members, patients,
and investigators who contributed to the BBI-825 program,” said
Zachary Hornby, President and CEO of Boundless Bio. “With this
strategic decision, we are prioritizing resource allocation to
BBI-355, which remains on-track for initial clinical
proof-of-concept data in 2025, and our novel ecDTx 3 program, where
we’ve made substantial preclinical progress and expect to nominate
a development candidate by mid-2025. It also extends our operating
runway into 2027, well beyond the anticipated milestones for both
BBI-355 and ecDTx 3.”
Mr. Hornby added, “At Boundless, we are seeking to improve
outcomes for high unmet need oncogene amplified cancer patients by
tackling complex challenges in cancer biology. I would like to
sincerely thank both Klaus and Neil for their instrumental
contributions to that work over the past several years and wish
them well as they move to their next professional chapters. Looking
ahead, we remain diligently focused on delivering meaningful
outcomes for patients and other stakeholders and look forward to
reporting on our progress in 2025.”
About Boundless BioBoundless Bio is a
clinical-stage oncology company dedicated to unlocking a new
paradigm in cancer therapeutics to address the significant unmet
need of patients with oncogene amplified tumors by targeting
extrachromosomal DNA (ecDNA), a root cause of oncogene
amplification observed in more than 14% of cancer patients.
Boundless Bio is developing the first ecDNA-directed therapeutic
candidate (ecDTx), BBI-355, which is an oral inhibitor of
checkpoint kinase 1 (CHK1) being evaluated in a Phase 1/2 clinical
trial in patients with oncogene amplified cancers. Boundless Bio’s
second ecDTx, BBI-825, is an oral inhibitor of ribonucleotide
reductase (RNR) that has been evaluated in a Phase 1/2 clinical
trial in cancer patients with resistance gene amplifications.
Leveraging its Spyglass platform, Boundless Bio has additional
programs advancing through preclinical development and discovery.
Boundless Bio is headquartered in San Diego, CA. For more
information, visit www.boundlessbio.com and follow us
on LinkedIn and X.
Forward-Looking StatementsBoundless Bio
cautions you that statements contained in this press release
regarding matters that are not historical facts are forward-looking
statements. The forward-looking statements are based on our current
beliefs and expectations and include but are not limited to: the
timing of expected data readout for the Phase 1/2 POTENTIATE
clinical trial, and new development candidate nomination and
submission of an IND application for ecDTx 3; the sufficiency of
our cash position to fund operations through anticipated initial
clinical proof-of-concept data readout for the Phase 1/2 POTENTIATE
clinical trial, nomination of a new development candidate and
submission of an IND application for a new development candidate
for ecDTx 3 and into 2027; the company’s plan to not advance the
BBI-825 program; and the potential safety and therapeutic benefits
of our ecDTx in treating patients with oncogene amplified cancers.
Actual results may differ from those set forth in this press
release due to the risks and uncertainties inherent in our
business, including, without limitation: we are early in our
development efforts and our approach to discover and develop ecDTx
directed against ecDNA in oncogene amplified cancers is novel and
unproven; results from preclinical studies or early clinical trials
not necessarily being predictive of future results; analytical
validation of an ecDNA diagnostic not necessarily being predictive
of its clinical validity and utility; potential delays in the
commencement, enrollment, data readouts or completion of clinical
trials or preclinical studies or submission of an IND; potential
difficulty or delay in transitioning the CMO position and any
resulting adverse impacts on our development programs or otherwise;
our dependence on third parties in connection with clinical trials,
preclinical studies, ecDNA diagnostic development, and
manufacturing; unfavorable results from clinical trials or
preclinical studies; we may expend our limited resources to pursue
a particular ecDTx and fail to capitalize on ecDTx with greater
development or commercial potential; unexpected adverse side
effects or inadequate efficacy of our ecDTx that may limit their
development, regulatory approval, and/or commercialization; the
potential for our programs and prospects to be negatively impacted
by developments relating to our competitors, including the results
of studies or regulatory determinations relating to our
competitors; regulatory developments in the United States and
foreign countries; efforts to streamline operations may not produce
the efficiencies expected; we may use our capital resources sooner
than we expect; and other risks described in our filings with the
Securities and Exchange Commission (SEC), including under the
heading “Risk Factors” in our quarterly report on Form 10-Q for the
quarter ended March 31, 2024 and any subsequent filings with the
SEC. You are cautioned not to place undue reliance on these
forward-looking statements, which speak only as of the date hereof,
and we undertake no obligation to update such statements to reflect
events that occur or circumstances that exist after the date
hereof. All forward-looking statements are qualified in their
entirety by this cautionary statement, which is made under the safe
harbor provisions of the Private Securities Litigation Reform Act
of 1995.
Contacts:
InvestorsRenee LeckTHRUST Strategic
Communicationsrenee@thrustsc.com
MediaCarly
Scadutocarly@carlyscadutoconsulting.com
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